children with recurrent respiratory symptoms)
Conditions
Interventions
Trade Name: Qvar Extrafijne Aerosol 100 inhalator
Pharmaceutical Form: Inhalation gas
Pharmaceutical form of the placebo: Inhalation gas
Route of administration of the placebo: Inhalation use
Sponsors
Netherlands Asthma Foundation (NAF)
Stichting astma bestrijding
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children aged 2-3 years, with recurrent respiratory symptoms suggestive of astma; Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: mental retardation, cardiac abnormalities, congenital anomalies, other respiratory diseases, chronic inflammatory diseases (e.g. Morbus Crohn, rheumatoid arthritis), inability to perform the exhaled air and lungfunction procedures properly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: As good responsiveness to corticosteroids is a hallmark of asthma (1), this response is likely able to discriminate between asthmatic children and non-asthmatic subjects. So far, response to inhaled corticosteroids has not been used as a predictor of asthma in studies, although several international guidelines advocate a trial treatment with inhaled corticosteroids for a likely diagnosis of asthma in young children. This study can test whether such guideline advises hold in clinical practice. ;Secondary Objective: ;Primary end point(s): Effects of medication on: - Nitric oxide (NO) in exhaled breath - Breathogram of volatile substances in expired air - Exhaled breath condensate - Lungfunction measurements of airway resistance - Respiratory symptoms and quality of life | — |
Countries
Netherlands
Outcome results
None listed